Forest Laboratories Submits New Drug Application for Levomilnacipran for the Treatment of Major Depressive Disorder

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NEW YORK & CASTRES, France--(BUSINESS WIRE)--Forest Laboratories, Inc. (NYSE: FRX) and Pierre Fabre Laboratories todayannounced that Forest has submitted a New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA) for levomilnacipran, a
serotonin norepinephrine reuptake inhibitor (SNRI) for the treatment of
Major Depressive Disorder (MDD) in adults. Levomilnacipran was
discovered by Pierre Fabre and jointly developed by Forest Laboratories
and Pierre Fabre, under a licensing agreement in the U.S. and Canada.
Pierre Fabre will be the active pharmaceutical ingredient (API) supplier.

The application includes results from three positive Phase III studies
comprising two double-blind, fixed-dose studies and one flexible-dose
study evaluating the efficacy of levomilnacipran compared with placebo
in adults with MDD. A total of more than 1,600 adult patients received a
once-daily dose of either levomilnacipran (40, 80, 120mg) or placebo in
the three studies. In each of the three studies, statistically
significant improvement was seen for the levomilnacipran group compared
with placebo in the primary and secondary endpoints (change from
baseline to endpoint in the Montgomery-Åsberg Depression Rating Scale
total score and Sheehan Disability Scale total score, respectively)
using the mixed-effects model for repeated measures and
last-observation-carried-forward analyses.

Additionally, safety data collected from the Phase III program
demonstrated that levomilnacipran 40, 80, 120mg once daily was generally
well tolerated, with an incidence of adverse reactions that was
consistent across the study treatment arms. The most commonly reported
adverse reaction (≥10% and twice the rate of placebo) observed in the
levomilnacipran group was nausea.

About Levomilnacipran

Levomilnacipran (1S, 2R-milnacipran), an enantiomer of racemic
milnacipran, is protected by a method of use patent that extends through
June 2023, without patent term extension. An SNRI, levomilnacipran has
greater potency for norepinephrine reuptake inhibition than for
serotonin reuptake inhibition in vitro without directly affecting the
uptake of dopamine or other neurotransmitters. Levomilnacipran has been
developed as a sustained-release formulation, dosed once daily.

About MDD

MDD is a serious medical condition requiring treatment, affecting more
than 15 million adults in the United States yearly or approximately 7.3%
of the adult U.S. population. People diagnosed with MDD may have a
combination of symptoms that can interfere with their ability to work,
sleep, study, eat, or enjoy once-pleasurable activities. Depression
costs the U.S. an estimated $44 billion each year. Among all medical
illnesses, MDD is a leading cause of disability in the U.S. The World
Health Organization predicts depression will become the second leading
cause of disability by the year 2020.

About Pierre Fabre Laboratories

Pierre Fabre, the second largest independent pharmaceutical group in
France, achieved a turnover of 1.9 billion Euros in 2011, with
international sales accounting for 52%. Pierre Fabre has branches in 42
countries and markets its products in over 130 countries. Their
activities cover all aspects of healthcare, from prescription drugs and
family health products to dermo-cosmetics. The Pierre Fabre Laboratories
employ some 10,000 people worldwide, 1,300 of whom are dedicated to R&D.
In 2011, the group allocated 20% of its Pharmaceuticals business
revenues to R&D, focusing on four main areas: oncology, dermatology,
neuropsychiatry and women’s health. With brands including Avène,
A-Derma, Ducray, Glytone, Klorane, René Furterer, Pierre Fabre
Dermatology or Pierre Fabre Oral Care, Pierre Fabre is market leader in
France when it comes to cosmetics, hair care, oral products and
dermatological products sold in pharmacies. Avène is marketed in over
100 countries, and is the leading dermo-cosmetics brand sold in Europe,
Japan and China. In the oncology area, 85% of Pierre Fabre’s sales are
achieved outside France. Levomilnacipran was discovered by Pierre Fabre
and is licensed to Forest Laboratories Inc. in the US and Canada.
Pierre-Fabre will also be the active pharmaceutical ingredient (API)
supplier. To find out more, go to www.pierre-fabre.com.

About Forest Laboratories

Forest Laboratories’ (NYSE: FRX) longstanding global partnerships and
track record developing and marketing pharmaceutical products in the
United States have yielded its well-established central nervous system
and cardiovascular franchises and innovations in anti-infective,
respiratory, gastrointestinal, and pain management medicine. Forest’s
pipeline, the most robust in its history, includes product candidates in
all stages of development across a wide range of therapeutic areas.
Forest is headquartered in New York, NY. To learn more, visit www.FRX.com.

Except for the historical information contained herein, this release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a
number of risks and uncertainties, including the difficulty of
predicting FDA approvals, the acceptance and demand for new
pharmaceutical products, the impact of competitive products and pricing,
the timely development and launch of new products, and the risk factors
listed from time to time in Forest Laboratories' Annual Reports on Form
10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
Forest assumes no obligation to update forward looking statements
contained in this release to reflect new information or future events or
developments.

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About Actavis + Forest

On July 1, 2014, Actavis (NYSE:ACT) completed the acquisition of Forest Laboratories, creating one of the world’s fastest-growing specialty pharmaceutical companies with annual revenues of more than $15 billion anticipated for 2015. The combination creates a Company with size and scale, a balanced offering of strong brands and generics, a focus on strategic, lower-risk drug development and a generic DNA, focused on cost efficiency across the expanded organization.

Careers

Join one of the world’s fastest-growing specialty pharmaceutical companies. The combination of Actavis + Forest is creating exciting career opportunities across our now larger and stronger global company. As we continue integrating our recruiting processes and systems, you may view career opportunities at the Actavis and Forest career sites.